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Herbal formulation clinical trial on Cognitive adult patient

A randomized, double-blind, placebo-controlled clinical study to evaluate comparative clinical Efficacy and Safety of BHC9612CP on Cognitive Function in Adult Subjects

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/02/023297
Enrollment
30
Registered
2020-02-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q049- Congenital malformation of brain,unspecified

Interventions

Intervention1: BHC9612CP Capsule Test product: Capsule dosage form Three times daily after meal Control Intervention1: Placebo: Capsule dosage form Three times daily after meal

Sponsors

Botanic Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Both male and female subjects aged between 40-75 years with a complaint of memory impairment for at least one year without any major cognitive deficit. 2.Subjects who are willing to sign ICF

Exclusion criteria

Exclusion criteria: 1.Subjects with Psychiatric disorders 2.Subjects with alcohol consumption 3.Subjects with any organ system infection in past 30 days 4.Subjects with severe cognitive problems like dementia, function disability, post 5.vascular cerebral symptoms or with any neurological problems

Design outcomes

Primary

MeasureTime frame
To study the efficacy and safety of Ashwagandha in subjects with cognitive impairmentTimepoint: Day 0 Day 28 and Day 56

Secondary

MeasureTime frame
1.Adverse events (AEs), frequency and severity. 2.Number of subjects who discontinue study due to adverse events 3.Changes in vital parameters and laboratory investigations Timepoint: Day 0 Day 28 and Day 56

Countries

India

Contacts

Public ContactDrShubarani

Bangalore Clinical Services

dr.shubharani111@gmail.com9449453674

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026